510(k) clearances

Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)

Xiamen Compower Medical Tech. Co., Ltd. · Anesthesiology

K263254Substantially EquivalentSpecialBTM
Open FDA's page for this record
Third party flag
N
City
Xiamen
Advisory committee description
Anesthesiology
Address 1
Unit 301, #16, Xianghong Rd., Xiang’An Torch Industrial Zone
Statement or summary
Statement
Product code
BTM
Zip code
361101
Applicant
Xiamen Compower Medical Tech. Co., Ltd.
Decision date
2026-10-16
Decision code
SESE
Country code
CN
Device name
Disposable Manual Resuscitator (NPVC-001/RTMA;NPVC-002/RTMA;NPVC-003/RTMA1)
Advisory committee
AN
Contact
Jenny Chen
K number
K263254
Date received
2026-09-17
Review advisory committee
AN
Postal code
361101
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Ventilator, Emergency, Manual (Resuscitator)
Medical specialty description
Anesthesiology
Regulation number
868.5915
Device class
2
Registration number
3003898360, 3005587132, 3020460367, 1417592, 2025816, 9617604, 2022648, 3027977504, 1924066, 9616445, 3007734888, 3011503227, 3014579161, 3008729547, 3012311599, 8043316, 9610849, 3013484413, 3003924186, 3015191173, 3006783791, 3036470679, 3008261717, 3014220748, 9610691, 3008806809, 3030308442, 3003862188, 3014656749, 3010272829, 1314417, 2518436, 3005621729, 3005609751, 9610483, 9610861, 3011987967, 9612374, 3008311916, 8021995 +34 more
FEI number
3003898360, 3005587132, 3020460367, 1417592, 2025816, 3003202124, 2022648, 3027977504, 1924066, 3002558692, 3007734888, 3011503227, 3014579161, 3008729547, 3012311599, 3003319165, 3006363476, 3013484413, 3003924186, 3005749238, 3015191173, 3003256355, 1000283452, 3006783791, 3036470679, 3008261717, 3014220748, 3002807836, 3008806809, 3030308442, 3003862188, 3000213164, 3014656749, 3010272829, 1314417, 3003418980, 2518436, 3005621729, 3005609751, 3011987967 +34 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.